Identity
- Trade Name
- HORIZON TITANIUM SUBTALAR 7MM FDA UDI
- Generic Name
- Subtalar implant, non-bioabsorbable FDA UDI
- Model / Reference
- 17803 FDA UDI
Identifiers
- Primary DI / UDI-DI
- M209178030 FDA UDI
- 510(k) Number
- K041936 FDA UDI
- FDA Product Code
- HWC FDA UDI
- GMDN Term
- Subtalar implant, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Conditional FDA UDI
Horizon Titanium Subtalar 7mm by Biopro, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K041936 also covers:
- Driver — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 10MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 11MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 12MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 8MM — BIOPRO, INC.
- HORIZON HYBRID SUBTALAR 9MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 10MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 11MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 6MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 8MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 2 9MM — BIOPRO, INC.
- HORIZON SUBTALAR GEN 212MM — BIOPRO, INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Biopro, Inc.
Sources (1)
- FDA UDI 559b3634-598a-431d-807c-d281b46e3713 34 fields · synced May 30, 2026